Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2025-12-30 @ 7:48 PM
Study NCT ID:
NCT05411250
Status:
UNKNOWN
Last Update Posted:
2022-06-09
First Post:
2022-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Diagnosis of Therapy-associated Cardiotoxicity Basing on PET/CT in Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D066126', 'term': 'Cardiotoxicity'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-06', 'studyFirstSubmitDate': '2022-06-06', 'studyFirstSubmitQcDate': '2022-06-06', 'lastUpdatePostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SUVmax', 'timeFrame': '150 days', 'description': 'the standardized uptake value'}], 'secondaryOutcomes': [{'measure': 'SUVR', 'timeFrame': '150 days', 'description': 'the ratio of the standardized uptake value for the heart to the normal tissue such as hepatic blood poor and gluteus'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiotoxicity', 'early'], 'conditions': ['Positron-Emission Tomography']}, 'descriptionModule': {'briefSummary': 'To explore the value of 18F-fluorodeoxyglucose (FDG) PET/CT imaging in early diagnosis of treatment-related cardiotoxicity (TACT) of lymphoma using visual method and semi-quantitative method.', 'detailedDescription': "First of all, the cardiac 18F-FDG uptake in patients with lymphoma will be observed by visual method: according to the uptake site, it will be divided into left ventricular uptake and biventricular uptake, and according to the degree of uptake, it will be divided into equal uptake (myocardial uptake is lower than cardiac blood pool uptake), moderate uptake (myocardial uptake is between cardiac blood pool uptake and liver uptake) and high uptake (myocardial uptake is higher than liver uptake). According to the uptake pattern, it can be divided into diffuse and segmental uptake.Then,using the region of interest method to mesure the value of myocardial uptake of 18F-FDG.The difference value of heart's SUVmax (Δ SUVmax- heart) and% Δ SUVmax- heart before and after chemotherapy or immunotherapy will be calculated. And SUVmax- heart / SUVmax- mediastinum ratio, SUVmax- heart / SUVmax- liver ratio and SUVmax- heart / SUVmax- background ratio (left gluteal muscle) after treatment. Taking the abnormality of ECG (early TACT) as the end point."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with malignant tumor after chemotherapy or immunotherapy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. No previous history of heart disease.\n2. normal echocardiography, ECG and laboratory tests (creatine kinase, myoglobin, troponin, brain natriuretic peptide) before treatment.\n\n3.18F-FDG PET/CT examination before and after treatment\n\n\\-\n\nExclusion Criteria:\n\n1.receiving radiotherapy and chemotherapy at the same time. 2.previous chest radiotherapy. 3. with severe hepatic or renal dysfunction.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05411250', 'briefTitle': 'Early Diagnosis of Therapy-associated Cardiotoxicity Basing on PET/CT in Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'Early Diagnosis of Therapy-associated Cardiotoxicity Basing on PET/CT in Lymphoma', 'orgStudyIdInfo': {'id': 'XW-Heart-002'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xuejuan Wang, MD', 'role': 'CONTACT', 'email': 'xuejuan_wang@hotmail.com', 'phone': '8601088196363'}], 'overallOfficials': [{'name': 'Zhi Yang, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking cancer hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal INvestigaor', 'investigatorFullName': 'Xuejuan Wang,MD', 'investigatorAffiliation': 'Peking University Cancer Hospital & Institute'}}}}